BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAC-ASSIST SUCTION UNIT

    MDR report key: 4213409 · Received October 23, 2014

    Report

    Report Number
    3003803075-2014-00001
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Date of Event
    June 11, 2014
    Report Date
    October 23, 2014
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Product Code
    JCX
    PMA / PMN Number
    K042349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE DETERMINATION FOR THE ISSUE: THE SUPPLIER DID NOT CHECK COMPLETELY BEFORE SHIPMENT, CAUSING SOME INCOMING SUCTION CANISTER LIDS WITHOUT THROUGH-HOLES; THE SCREW OF MOLDING THROUGH-HOLE ROD OF THE SUPPLIER HAS COME LOOSE, CAUSING SOME SUCTION CANISTER LIDS WITHOUT THROUGH-HOLES, THE PHOTO OF MOLDING THROUGH-HOLE ROD; AFTER THE ABOVE ANALYSIS, WE DETERMINED THE ROOT CAUSE IS A MOLDING ISSUE WHICH RESULTS IN THE PATIENT PORTS OF LIDS ON THE CANISTERS BEING SEALED BY PLASTIC. THE CAPA TAKEN TO PREVENT RECURRENCE OF THE ISSUE: CONTRACT MANUFACTURER TO MODIFY CANISTER LID MOLD; CONTRACT MANUFACTURER TO CONDUCT 100% INSPECTION OF FINISHED GOODS; (B)(4). TO UPDATE INCOMING QUALITY CONTROL AND FINISHED GOODS QUALITY CONTROL PROCEDURES TO INCLUDE A VISUAL INSPECTION OF PORTS ON CANISTER LIDS. THE VOLUNTARILY RECALL: A VOLUNTARILY RECALL HAS BEEN CONDUCTED SINCE AUGUST 6, 2014, THE RECALL NUMBER OF WHICH IS Z-2642-2014. THE REASON WHY SUBMITTING MDR: AT FIRST, WE WERE INFORMED OF JUST FEW DEFECTIVE CANISTER LIDS FROM OUR CUSTOMER (B)(4), BUT THERE WERE MORE AND MORE LATER. SO WE DECIDE TO SUBMIT THIS MDR.

    Description of Event or Problem · 1

    SOME SUCTION UNITS CONTAIN SUCTION CANISTER LIDS THAT MAY OCCLUDE PORTS, WHICH RESULTED IN NO SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674717 VAC-ASSIST SUCTION UNIT POWERED SUCTION PUMP, 878.4780 JCX EMG TECHNOLOGY CO., LTD. HCS7000

    Patients

    Seq Age Sex Outcome Treatment
    1